In an update for the year ended 31 May 2021 Oncimmune (ONC ) said it has delivered “outstanding top line growth” as FY21 revenues saw a more than eightfold increase on FY20. 

The global immunodiagnostics group reported FY21 revenues in line with market expectations at £5.6m (FY20: £0.7m after the company succesfully managed to ‘tightly’ control its cost base in FY21 after implementing a cost reduction programme in FY20. 

Oncimmune successfully completed an equity placing in March 2021, raising £9m to provide additional funding to increase its ImmunoINSIGHTS commercial team headcount, principally in the US, and to increase its operational capacity at its lab facility in Dortmund, Germany. 

To date, the company said its programme to increase capacity to approximately 40,000 samples per annum by Q1 FY23, is ‘proceeding to plan’ and will enable the Company to meet the increasing the demand from customers for its ImmunoINSIGHTS service offering.  

In particular, Oncimmune said its ImmunoINSIGHTS offering has emerged through the global pandemic in FY21 ‘as a robust and resilient growth engine for the Company,’ 

Over the year, the company secured major contracts for its ImmunoINSIGHTS division, including with Roche Pharmaceuticals and Genentech, a member of the Roche Group. 

In 4Q21, the Company launched its proprietary Infectious Diseases panel and shortly thereafter signed substantial new contracts with Roche and Cedars-Sinai Medical Center, with the majority of revenue from these contracts due to be realised in FY22. 

It also signed a new autoantibody profiling study with a leading US-based global pharmaceutical firm in 4Q21 to evaluate the autoantibody profiles of patient samples in immuno-oncology and autoimmune trials and which is scheduled for completion in 2Q22. 

In 4Q21, Oncimmune extended an existing agreement with Cedars-Sinai Medical Center whereby it will analyse samples from COVID-19 projects using its proprietary Infectious Diseases panel to support COVID-19 research into the immune response to the disease. 

Within the EarlyCDT® product business, which has seen strong recovery demand within the US, the Company said it has signed commercial contracts to supply the EarlyCDT Lung blood test within the NHS. Since these were signed, the firm has agreed a further NHS supply contract in 4Q21 which is scheduled to commence revenue generation from 1Q22. 

Oncimmune said it expects to sign new contracts in 1Q22 from its ImmunoINSIGHTS pipeline which, together with those contracts already signed in FY21, is expected to deliver revenue of around 50% of the FY22 market expectations for the ImmunoINSIGHTS business. 

‘With this high degree of visibility of revenue at the beginning of the financial year, we are confident in our ability to deliver management's revenue expectations for FY22,’ it said. 

In terms of growth in the ImmunoINSIGHTS commercial pipeline, the firm cited potential plans to establish a duplicate lab facility in the US to directly service its US client base. 

In addition, Oncimmune said its EarlyCDT product business is beginning to see an improvement in commercial activity following the impact of COVID-19 on FY20 and FY21. 

Commenting on the results, Dr Adam M Hill, CEO of Oncimmune said: "Despite FY21 being a challenging year for us all with the backdrop of COVID-19, I have been humbled by the individual dedication and professional commitment shown by all within the Oncimmune team, enabling us to stick to the schedule laid out in our three-year forward strategy.  

We were able to deliver the second and third pillars of our strategy - moving into patient selection through partnerships with pharma companies - through the launch of ImmunoINSIGHTS, while we have continued to successfully access both the UK and US markets with EarlyCDT Lung providing sales channels from which we can build.” 

He added, “ImmunoINSIGHTS has also proven its ability as a stand-alone business, and we anticipate this will be an enabler of future investment and growth looking forward." 

View from Vox 

The company believes that the ImmunoINSIGHTS business, which has a current pipeline of over 100 separate opportunities, is now in a solid position to deliver ‘sustainable growth.’ 

Shares in Oncimmune have increased by nearly 30% in value since the beginning of 2021. The stock was trading 6.10% higher this morning at 215.5p following the announcement. 

Oncimmune Holdings’ focus is to harness the immune system’s sophisticated response to disease to detect cancer earlier and to support the development of better therapies. 

Leading Proprietary Technology Portfolio 

The company believes the key to improving cancer survival is early detection and optimal selection for therapy. Oncimmune's immuno-diagnostic test, EarlyCDT, can detect and help identify cancer on average four years earlier than standard clinical diagnosis. 

Oncimmune’s core technology also powers its ImmunoINSIGHTS service; a proprietary platform that enables life-science organisations to optimise drug development and delivery, leading to more effective, targeted as well as safer treatments for patients. 

The group’s EarlyCDT Lung blood test was previously featured on an ITV news broadcast last weekend titled ‘New Blood Test Provides Breakthrough in Lung Cancer Detection Rates’.  

The feature highlighted that, in the UK, more than 35,000 people die of lung cancer each year and most have their lung cancer diagnosed late thereby lowering their chances of survival. 80% of lung cancer cases are diagnosed in the latest stages of the disease.  

The EarlyCDT test works to identify the immune system's response to the presence of lung cancer. The test detects antibodies present in the body, enabling clinicians to focus their diagnosis on identifying the disease and treating it earlier than current clinical practice.  

It has previously been shown that Oncimmune’s EarlyCDT Lung blood test can detect lung cancer on average four years before standard of care and has shown in a large National Health Service (NHS) trial that it can reduce late stage lung cancer presentation by 36%. 

Inflection Point to Commercialisation 

The Company now believes it has made the point of inflection as it matures from an R&D business into a commercial entity evidenced through its deepening commercial relationships with Industry Partners such as Roche 

Fully Funded 

The Company is now fully funded to develop all its commercial activities and drive revenues. 

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